Role of Slow Waves in the Progression of Neurodegeneration in Isolated REM Sleep Behavior Disorder
University of Zurich
80 participants
Jan 15, 2026
INTERVENTIONAL
Conditions
Summary
This study tests whether enhancing deep sleep with gentle sounds at night can slow progression in people with iRBD or early Parkinson's disease. Participants wear a sensor headband and headphones for 18 months. Four assessments including mobility, memory, imaging (PET/MRI), lumbar puncture, and blood tests are assessed.
Eligibility
Inclusion Criteria8
- Signed informed consent
- Diagnosis of polysomnography-confirmed isolated REM Sleep Behavior Disorder (iRBD) based on international criteria (ICSD-3), combined with EITHER
- UPDRS III without action tremor ≥ 4 AND abnormal olfaction, OR
- diagnosis of PD along international criteria for less than 2 years
- no dopaminergic treatment and no foreseen start of such treatment during duration of the study
- ability to apply the intervention, alone or with help of a co-habitant, stable living situation
- sufficient language skills in German, French or Italian
- negative pregnancy test for women of child-bearing potential
Exclusion Criteria17
- Suspected or known non-compliance to other therapies
- current or recent participation in another clinical trial
- extended absences
- hearing impairment that prevents hearing the tones for auditory stimulation
- non-responder to auditory stimulation during screening
- clinically significant concomitant disease or unstable condition
- Apnea-Hypopnea-Index (AHI) \> 15/h or under Continuous Positive Airway Pressure (CPAP) treatment
- Restless Legs Syndrome
- meeting criteria for diagnosis of atypical Parkinson syndrome
- diagnosis of Dementia or Montreal Cognitive Assessment (MoCA) \< 24
- severe Depression or other psychiatric disorder
- regular use of benzodiazepines and other central nervous system depressant substances
- current or recent history within the last year of substance abuse disorders or chronic alcohol consumption
- recent or planned major surgery
- history of allergies and hypersensitivity relevant for electrode application or medication allergies
- any criterion that may pose the participant at risk
- breastfeeding, intention to become pregnant, or unwillingness to use medically reliable contraception for women of child-bearing potential
Interventions
Phase Targeted Auditory Stimulation (PTAS) will be applied through integrated headphones with a portable EEG device when non-rapid-eye-movement (NREM) sleep is detected during the night.
Auditory stimuli will be delivered during the night through integrated headphones with a portable EEG device in a non-PTAS manner.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07355842